Written Educational Information and Phone Calls in Increasing Follow-Up Care in Hispanic Women With Abnormal Pap Smears

Cervical Cancer Clinical Trial

Official title:

Wake Forest University Cervical Screening and Follow Up System for Hispanic Women - A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00483288
• Other study ID #: CCCWFU-30104B
• Secondary ID: CDR0000547179CCC
• Status: Completed
• Phase: N/A
• First received: June 6, 2007
• Last updated: January 17, 2017
• Start date: May 2005

Study information

• Verified date: June 2013
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Written educational materials and counseling by phone may help promote follow-up care in women with abnormal Pap smears.

PURPOSE: This clinical trial is studying how well written educational information and phone calls work in increasing follow-up care in Hispanic women with abnormal Pap smears.

Description:

OBJECTIVES:

Primary

• Determine the reasons for nonadherence to follow-up in Hispanic women with abnormal Pap smear findings.

• Assess the effect of written educational information and phone calls on follow-up rate in these patients.

OUTLINE: This is a pilot, cross-sectional, controlled, multicenter study. Patients are sequentially assigned to 1 of 3 intervention groups.

• Group 1 (control): Patients complete a standardized Spanish survey questionnaire, assessing their demographic information, knowledge, attitudes, behaviors, experiences with cervical screening, past medical history, and prior treatment, either in person (for those who kept their colposcopy appointment) or over the telephone (for those who did not keep their colposcopy appointment). Additional questions are added for patients who did not keep their colposcopy appointment to test for differences and to learn the reasons for not keeping their appointment.

• Group 2 (written educational information): Patients receive notification of their colposcopy appointment and an educational letter about Pap smears, cervical cancer risk, and the purpose and procedure of colposcopy. They complete the standardized Spanish survey questionnaire as in group 1.

• Group 3 (phone call): Patients receive notification of their colposcopy appointment and a personal telephone call educating them about Pap smears, cervical cancer risk, and the purpose and procedure of colposcopy. They complete the standardized Spanish survey questionnaire as in group 1.

All patients are asked to agree to submit residual Pap smear fluid to the Comprehensive Cancer Center of Wake Forest University tumor bank, and be included in a tracking system to insure future follow-up communications.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 238
• Est. primary completion date: September 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

DISEASE CHARACTERISTICS:

• Abnormal Pap smear findings indicating the need for further treatment at the colposcopy clinic

• Scheduled for colposcopy at the Comprehensive Cancer Center of Wake Forest University

• No history of invasive cervical cancer

PATIENT CHARACTERISTICS:

• Must be of Hispanic background, including any of the following:

• Hispanic

• Latino

• Chicano

• Mexican American

• Puerto Rican

• Cuban American

PRIOR CONCURRENT THERAPY:

• Not specified

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

Other:
• educational intervention

• questionnaire administration

• study of socioeconomic and demographic variables

• survey administration

Locations

Country	Name	City	State
United States	Wake Forest University Comprehensive Cancer Center	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reasons for nonadherence to follow-up
Primary	Effect of written educational information and phone calls on follow-up rate